Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients
NCT ID: NCT03842813
Last Updated: 2021-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1030 participants
OBSERVATIONAL
2019-04-09
2022-07-31
Brief Summary
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As routine care, each patient will be followed until 12 months after stent implantation.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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DES-CRE8
Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption.
Eligibility Criteria
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Inclusion Criteria
* patient informed and agreed to participate,
* patient with one or more lesions treated with one or more coronary stent CRE8,
* patient with a diabete insulin dependent or non-insulin dependant.
Exclusion Criteria
* patient who refused to participate,
* patient with another lesion treated during the same intervention with a balloon alone or with another stent
18 Years
ALL
No
Sponsors
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EVAMED
OTHER
Alvimedica Medical Technologies France
INDUSTRY
Responsible Party
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Principal Investigators
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Julien Vandenwildenberg
Role: STUDY_CHAIR
Alvimedica Medical France
Locations
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Clinique de l'Europe
Amiens, , France
Centre Hospitalier Avignon
Avignon, , France
Centre Hospitalier Beauvais
Beauvais, , France
Clinique Convert
Bourg-en-Bresse, , France
Centre Hospitalier Brive
Brive-la-Gaillarde, , France
Centre Hospitalier Chartres
Chartres, , France
Hôpital Schweitzer
Colmar, , France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, , France
Hôpital Privé de Bourgogne
Dijon, , France
Hôpital Simone Veil
Eaubonne, , France
Clinique Pasteur
Essey-lès-Nancy, , France
Centre Hospitalier Gonesse
Gonesse, , France
Centre Hospitalier Universitaire Grenoble
Grenoble, , France
Centre Hospitalier Haguenau
Haguenau, , France
Centre Hospitalier Saint-Joseph Saint-Luc
Lyon, , France
Clinique Pont de Chaumes
Montauban, , France
Centre Hospitalier Pau
Pau, , France
Clinique Saint-Hilaire
Rouen, , France
Centre Hospitalier Saint-Quentin
Saint-Quentin, , France
Clinique Saint-Joseph
Trélazé, , France
Centre Hospitalier Valence
Valence, , France
Centre Hospitalier Vannes
Vannes, , France
Countries
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Other Identifiers
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2018-A02663-52
Identifier Type: -
Identifier Source: org_study_id
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